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Dexamethasone for Post-Cesarean Pain

Phase 4
Recruiting
Led By Victoria Wesevich, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 72 hours of surgery
Awards & highlights

Study Summary

This trial is looking at whether giving a steroid called dexamethasone to pregnant women with a history of opioid use disorder who are on medication assisted treatment improves their pain scores and decreases their opioid use after having a cesarean section.

Who is the study for?
This trial is for English-speaking individuals scheduled for an elective cesarean delivery, with a history of opioid use disorder currently on medication-assisted treatment. They must have a negative drug screen upon hospital admission and not have received certain steroids within 24 hours before the c-section.Check my eligibility
What is being tested?
The study is testing if dexamethasone given after surgery can improve pain management and reduce opioid use in patients post-cesarean section compared to a placebo. Participants will be randomly assigned to receive either dexamethasone or a placebo.See study design
What are the potential side effects?
Dexamethasone may cause side effects such as increased blood sugar levels, possible infections, mood swings, insomnia, and stomach irritation. The severity of these side effects varies from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 72 hours of surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 72 hours of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
improvement in pain score
Secondary outcome measures
change of morphine use

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: patients receiving dexamethasoneExperimental Treatment1 Intervention
subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline
Group II: placeboPlacebo Group1 Intervention
100mL of normal saline (placebo) immediately upon the subjects' arrival to the Post Anesthesia Care Unit (PACU) after leaving the operating room from their scheduled c-section
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,401 Total Patients Enrolled
Victoria Wesevich, MDPrincipal InvestigatorYale School of Medicine

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04067609 — Phase 4
Post-Cesarean Pain Syndrome Research Study Groups: patients receiving dexamethasone, placebo
Post-Cesarean Pain Syndrome Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04067609 — Phase 4
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04067609 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Dexamethasone been validated by the FDA?

"The safety of Dexamethasone is backed by evidence from a Phase 4 trial and therefore has been rated 3 on our team's scale."

Answered by AI

What medical conditions does Dexamethasone typically address?

"Dexamethasone is frequently prescribed to ameliorate ophthalmia, sympathetic and additional eye-related disorders such as branch retinal vein occlusion or macular edema."

Answered by AI

Is there still availability for participants in this clinical research?

"Affirmative. Clinicaltrials.gov data indicates that this trial, which was first posted on July 20th 2020, is currently enrolling suitable candidates. 40 participants are being sought from one medical centre."

Answered by AI

What is the current enrolment of participants in this trial?

"Correct. The clinicaltrials.gov website indicates that the trial was initially advertised on July 20th 2020, and is currently in search of 40 participants for a single site."

Answered by AI

What past experiments have been conducted with Dexamethasone?

"Currently, 553 clinical studies involving Dexamethasone are ongoing with 144 of them in their terminal phase. Most trials for this drug take place at Mishawaka, Indiana however there is a total of 18618 sites active on the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Postoperative Dexamethasone on Post-Cesarean Pain
2020. "Postoperative Dexamethasone on Post-Cesarean Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04067609.
~5 spots leftby Nov 2024
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